Distillers won’t actually have to pay FDA thousands of dollars for making hand sanitizer

Lillian Stone
·2 min read
Man holding bottle of hand sanitizer in distillery factory setting
Man holding bottle of hand sanitizer in distillery factory setting


Long Island’s The Better Man Distilling Company manufactured hand sanitizer in April

If you’ve been paying attention, you know that the hospitality industry has completed all sorts of acrobatic pivots since the COVID-19 pandemic descended last year. (LAST. YEAR.) One such pivot took place during the Great Hand Sanitizer Run of 2020 when panic buyers cleared out store shelves and distilleries stepped in to aid consumers. But last week, distilleries across the country found that their shimmy into the the sanitizer business could cost them nearly $25,000 in Food and Drug Administration fees. Fortunately, the fees have since been waived.

Some background: on December 29, the FDA posted a notice and emailed some distilleries alerting them to two fees: a $14,060 Monograph Drug Facility Fee and a $9,373 Contract Manufacturing Organization Facility Fee. All because the distilleries heeded the call to produce more hand sanitizer. Distillers also had approximately six weeks to pay the fees, which were initially due on February 11. Finally, distillers were told that they had two days to de-register themselves as hand sanitizer manufacturers, lest they be changed the same fees again in 2022.

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Unsurprisingly, Distilled Spirits Council President and CEO Chris Swonger raised a ruckus. “While this fee may be a rounding error to a large pharmaceutical company, this will be disastrous to small distilleries who stepped up to help produce this critical product,” Swonger said in a statement. “It will quite literally bankrupt some struggling businesses.”

Fortunately, the U.S. Department of Health and Human Services later tweeted that a reprieve was in order:

The tweet, attributed to HHS Chief of Staff Brian Harrison, read: “I’m pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees. Happy New Year, distilleries, and cheers to you for helping keep us safe!” Cheers, indeed.